# K113165: Mini-Medic

- Pathway: 510(k) (Traditional)
- Applicant: Athena Gtx
- Decided: Feb 2, 2012 after 99 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 37 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101674: WVSM (Wireless Vital Signs Monitor), Model 5.0, Athena Gtx (2010) Summary page 1.
- K070193: Envitec Oxipen Pulse Oximeter and Accessories, Envitec-Wismar GmbH (2007) Summary page 1.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 1.
- K011918: Nihon  Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A Series, Nihon Kohden America, Inc. (2001) Summary page 1.
- K050056: Model 2500A Palmsat Pulse Oximeter, Nonin Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K222658: Accurate 24 Non-invasive blood pressure monitor (2023), 2 descendants of its own
- K250415: G0 Blood Pressure Monitoring System (G0) (2025), 1 descendant of its own

## Indications for use
The mini-MedicTM system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over. The mini-Medic TM system is indicated as a single or multi-parameter vital signs monitor for Sp02 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from EGG electrodes, and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from the integrated SpO2 forehead sensor and EGG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions. Patient data may be entered on the Handheld Display Unit. The mini-MedicTh system provides vital parameter alarms and a patient composite/summary alarm. Patient information and system commands are transmitted using wireless radio communications between the Forehead Sensor Unit and the Handheld Display Unit. Stored patient data may be output, printed, downloaded and saved via a dedicated mini-MedicTM PC Software application. Typical locations for the use of the mini-Med ic TM system are: pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport. The monitor is intended to be used by trained healthcare providers in military and civilian roles including doctors, nurses, combat medics, combat lifesavers, EMT's, and paramedics.

Source page: https://510kreport.com/device/K113165
Methodology: https://510kreport.com/methodology